In (or Out of) the Marketplace of Ideas: WARF v. Geron and Lessons for Canada

Four days after President George W. Bush addressed America regarding human embryonic stem cell ( hESC ) research in August 2001, a lawsuit was filed by the Wisconsin Alumni Research Foundation (“WARF”) against Geron Corporation ( Geron ). WARF holds patents in respect of hESC technologies pioneered by James Thomson. The parties were unable to negotiate licences for additional hESC types. In January 2002, WARF and Geron announced that a new agreement had been reached. This paper examines the antecedent question: should the hESC technologies have been patentable in the first place? The reason for pursuing hESC research appears to be the possibility to improve human health. But hESC research also carries great economic potential. Express prioritization of these dual benefits is lacking. The practice of patenting hESC technologies provides a clue. The empirical support for the proposition that patent rights increase scientific innovation is minimal. Two arguments favour the status quo: 1.the researchers who \u27invent\u27 the technologies are entitled to a property right (Lockean argument); and, 2. circumscribing access to secure investment is acceptable because an overall benefit is produced (utilitarian argument). However, both arguments rest on dubious premises. Most notably, the tragedy of the anticommons , added transaction costs, and depreciated scientific creativity undermine the claim that a net benefit will accrue. Preserving the current regime therefore attaches higher priority to commercial interests. Two responses are left: modifying the patent system or placing hESC technologies in the public domain. Only the latter will ensure that the potential health benefits of hESC research are the top priority

Banning Bans on New Reproductive and Novel Genetic Technologies

Commentators argue that statutory prohibitions with the force of the criminal law should not be used to regulate new reproductive technologies (NRTs) and novel genetic technologies (NGTs). Bill C-13, the Assisted Human Reproduction Act, however, codifies 10 criminal bans. This paper considers the merits of the various arguments levied against Bill C-13, and the corollary claim that only a non-prohibitive model of legislation befits NRTs and NGTs. Three types of arguments are used to critique criminal bans: (1) Structural arguments hinge on the constraints of the Canadian legal system - legislation complete with prohibitions runs afoul of the Constitution Act 1867, violates the Canadian Charter of Rights and Freedoms, and cannot keep pace with scientific progress. (2) Consequentialist arguments focus on the potential results of enacting a statute carrying criminal bans - criminalization will chill research, drive research underground, encourage researcher forum shopping, fuel public misperception by reinforcing genetic determinism, and effectively foreclose important dialogue on NRTs and NGTs. (3) Theoretical arguments relate to the very nature of criminal law - prohibitions will be unenforceable; the criminal law, a model of command and control , will be ineffective in shaping research practice; and moral ambiguity can support only regulation, as consensus is a sine qua none for criminal bans. All the arguments in opposition to criminal bans prove unpersuasive; moreover, they fail to substantiate a non-prohibitive alternative for NRT-NGT regulation. Bill C-13 should therefore be proclaimed into law; perhaps then commentators will actually theorize about the harms, or lack thereof, of particular NRTs and NGTs

Unlocking Health Canada’s Cache of Trade Secrets: Mandatory Disclosure of Clinical Trial Results

Health Canada should publicly disclose information about the safety and efficacy of pharmaceuticals, biologics and medical devices, and should especially disclose the designs and results of clinical trials. This disclosure is necessary to preserve public trust, address weaknesses in the evidence base, and protect Canadians from harm. A prime example of the need for this disclosure involves selective serotonin reuptake inhibitors (SSRIs). Health Canada did not authorize SSRIs for sale to people younger than 19 years because of data from clinical trials showing risks of harm, including self-harm, associated with use of SSRIs in that age group. But Health Canada also did not publicly disclose that evidence, and by 2004 SSRIs were being widely prescribed for teenagers. Physicians had no idea they were invoking their discretion to prescribe “off label” on the basis of incomplete information — the balance of which Health Canada had in hand. Assessing how often harm results from nondisclosure is difficult because reporting of adverse events remains poor. What is clear from several analyses is that there is often a chasm between the published scientific literature (which is biased toward positive results) and the information that regulators possess about a given drug. Why does Health Canada not divulge information from clinical trials until reports surface of widespread off-label prescribing? The reason is legal: the companies that manufacture these therapeutic products and devices claim that information is “confidential business information” or a “trade secret,” which they own, and which Health Canada is not free to disclose. I witnessed this pas de deux while attending Health Canada’s “technical discussions on regulatory modernization” held between October 2010 and January 2011. Each proposal put on the table by Health Canada to increase transparency — from making final decisions regarding applications for market authorization publicly available, to creating an online register of therapeutic products — was met with proprietary claims from MEDEC, BIOTECanada or Rx&D, the respective associations of medical device, biotechnology and pharmaceutical companies in Canada. Each time, Health Canada acknowledged that the law controlled what they could and could not disclose. In this article, I argue that the law, in fact, poses a minimal barrier to the disclosure of the designs and results of clinical trials. I begin by illustrating Health Canada’s tendency to keep third-party information secret, then show why — insofar as protecting third-party information has prevented the disclosure of the designs and results of clinical trials — this goes beyond what the law requires, in principle. I go on to highlight institutional barriers to changes in policy

Emerging Academic Scientists\u27 Exclusionary Encounters with Commercialization Law, Policy, and Practice

Academic laboratories are increasingly sites of commercialization While empirical evidence about the impact of the emphasis placed upon commercialization by governments research funding agencies and research institutions and the attendant growth of commercialization activities in the academic sphere has been gradually accumulating much of this evidence is tied to established academic scientists Comparatively little empirical research has focused upon emerging academic scientists Therefore the purpose of this chapter is to identify a set of concerns flowing from emerging academic scientists\u27 encounters with commercialization laws policies and practices The chapter proceeds in three parts In Part A I describe contextual changes related to commercialization in the academic realm as well as a range of commercialization activities that emerging scientists are increasingly apt to be exposed to as they pursue scientific careers In Part B I identify two exclusionary encounters that emerging scientists are likely to have with commercialization laws policies and practices These encounters pertain to 1 inventorship of patentable discoveries and 2 intellectual property ownership By way of brief conclusion in Part C I set out one hypothesis for future empirical inquir

Demythologizing PHOSITA - Applying the Non-Obviousness Requirement under Canadian Patent Law to Keep Knowledge in the Public Domain and Foster Innovation

The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical selection patent case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although the Court was cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped its attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the person having ordinary skill in the art (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation--one which assumes that actors consult patents to learn about scientific developments, devalues the importance of the public domain, and ignores the industry--specific nature of innovation. The article also describes the historical evolution of the non-obviousness test, identifies factors that undermine PHOSITA\u27s characterization, and develops a multi-layered prescription to remedy the problem

The Rhetoric of Innovation

Innovation has been lauded over centuries but the emergence of an innovation policy paradigm is a new phenomenon, producing profound changes in the realm of scientific research. Whether these changes stand to benefit \u27all\u27 Canadians remains to be seen. Therein lies a problem: The present innovation policy paradigm trades on society\u27s deeply entrenched view of innovation (however it occurs) as a public good, while simultaneously encoding for specific a \u27brand\u27 of innovation that privileges capital over all other interests. This thesis (1) demonstrates that this paradigm is the product of historically complex contests of power; (2) argues that the paradigm is \u27flawed\u27 (in terms of the model it is premised upon), \u27underinclusive\u27 (in terms of the practices it purports to monitor), and \u27misleading\u27 (in terms of the social outcomes it is assumed to produce); and, therefore (3) seeks to legitimize significant questions surrounding benefit-sharing, wealth redistribution, and sustainability

Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform

The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing upon a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor

Demythologizing PHOSITA - Applying the Non-Obviousness Requirement under Canadian Patent Law to Keep Knowledge in the Public Domain and Foster Innovation

The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical selection patent case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although the Court was cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped its attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the person having ordinary skill in the art (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation--one which assumes that actors consult patents to learn about scientific developments, devalues the importance of the public domain, and ignores the industry--specific nature of innovation. The article also describes the historical evolution of the non-obviousness test, identifies factors that undermine PHOSITA\u27s characterization, and develops a multi-layered prescription to remedy the problem

House of Commons’ Standing Committee on Health: Development of a National Pharmacare Program

Canada should implement national pharmacare consistent with the principles outlined in the Pharmacare 2020 report. (Morgan et al. 2015a) The best evidence we have shows that national pharmacare will save approximately $7 billion and — more importantly — hundreds of lives each year. (Morgan et al. 2015b) The issue, then, is not whether to institute national pharmacare, but how. For, even though the need for national pharmacare has been plain since the 1964 Hall Commission, the landscape of medicine and pharmaceuticals has changed dramatically since then. Of particular note is the pharmaceutical industry’s growing interest in drugs that target relatively small patient populations — often described interchangeably as ‘orphan’, ‘niche’, or ‘specialty’ drugs — in the pursuit of so-called ‘personalized’ or ‘precision medicine.’ This brief focuses specifically on the challenges posed by the push for more personalized medicine. These challenges serve to underscore why national pharmacare is needed, and define some of its essential features